Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92132
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Skin Irritation (2076)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on december 15, 2017, by cochlear ltd.On behalf of cochlear americas.(b)(4).
 
Event or Problem Description
Per the clinic, the patient developed skin irritation with re-occurring discharge and skin breakdown at the implant site.Subsequently, the patient was treated with silver nitrate cream locally, and a course of oral antibiotics (date not reported).The implanted device remains insitu.The patient will continue to be routinely managed by their healthcare provider.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
Common Device Name
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key7119259
Report Number6000034-2017-02356
Device Sequence Number1495697
Product Code MAH
UDI-Device Identifier09321502018951
UDI-Public(01)09321502018951
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K955713
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model Number92132
Device Catalogue Number92132
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/30/2017
Initial Report FDA Received Date12/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-